Syneos Health

Senior CDS Project Manager

Syneos Health

full-time

Posted on:

Location Type: Remote

Location: Remote • 🇺🇸 United States

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Ensures the contracted services and expectations of a clinical project are carried out by the Company project team in accordance with the executed contract and the Customer’s expectations.
  • Works in the role of a project manager on assigned project(s), which may range from single CDS projects to large full scope CDS projects.
  • Duties include primary liaison with Customers, Clinical team, Vendors, Functional leads, and Senior Management.
  • Acts as a mentor to other CDS (Clinical Development Services) Project Managers.
  • Acts as a primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and Company’s contractual agreement.
  • Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.
  • Serves as the team leader by overseeing the Biometrics project team.
  • Facilitates team building and communication.
  • Proactively monitors project resources and works with functional lead/management to ensure project requirements are met.
  • Manages multiple projects ranging in size and complexity from single service Biometrics projects to large full scope Biometrics projects, global projects and/or programs, with minimal interaction from supervisor.
  • Completes periodic review of tasks completed and backlog.
  • Works with internal teams like finance, accounts, contracts to ensure effective financial, contractual and invoice management and issue resolution.
  • Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports, and ensures adequate documentation of each communication.
  • Independently prepares information for internal review meetings and proactively manages action resolution to ensure project delivery.
  • Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
  • Produces and distributes status and tracking reports as well as functional area plan, to appropriate team members and senior management.
  • Networks to acquire new and/or repeat business.
  • Works with Business Development and the Proposal/Contracts groups to develop proposals for Customer requested opportunities as needed.

Requirements

  • BA/BS in life sciences, communications, nursing, or equivalent related education and experience.
  • 7 to 8+ years of Industry experience (preferably from PM in clinical data science/Biometrics background), able to handle independently.
  • Preferable to have experience in leading projects & deliverables across function CDM, MW, Biostats, Stats Prog, etc.
  • Responsible for managing project finances (Budget, Revenue Recognition), Contracts, Invoicing, Timeline planning (e.g. Microsoft Project), Risk assessment.
  • Leading a Biometrics/Clinical Data Science Project team and liaising with Clinical Team, Vendors & Clients.
  • Project management experience in a contract research organization, pharmaceutical, or Biotechnology Company preferred.
  • Experience actively managing clinical research projects across CDS functional areas.
  • Previous CRO experience and specific CDS management experience.
  • Other relevant experience preferred.
  • Thorough knowledge of major HA (e.g. FDA, EMEA, PMDA) regulations, drug development, and project management procedures.
  • Demonstrated proficiency with ICH/GCP guidelines.
  • Excellent communication skills.
  • Strong presentation, documentation, and interpersonal (emphasis on proactive leadership) skills as well as a team-oriented approach.
  • Proficient computer skills in Word, Excel, PowerPoint, MS Project, email and internet.
  • Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
  • High level of competence in English language.
  • Ability to travel up to 25%.
Benefits
  • health insurance
  • retirement plans
  • paid time off
  • flexible work arrangements
  • professional development
  • total rewards program

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
project managementclinical data sciencebudget managementrisk assessmenttimeline planningclinical researchdata managementbiostatisticsGood Clinical Practices (GCP)International Conference on Harmonization (ICH)
Soft skills
communicationleadershipinterpersonal skillsteam-orientedpresentation skillsdocumentation skillsflexibilityproblem-solvingmentoringnetworking